AGREEMENT between the European Community and the Government of Canada on sanitary measures to protect public and animal health in respect of trade in live animals and animal products

THE EUROPEAN COMMUNITY (the 'Community`)

and

THE GOVERNMENT OF CANADA ('Canada`)

hereinafter referred to collectively as the 'Parties`:

ACKNOWLEDGING that their systems of sanitary measures are intended to provide comparable health assurances;

REAFFIRMING their commitment to their rights and obligations under the Marrakesh Agreement establishing the World Trade Organisation (the 'WTO Agreement`), and its Annexes, in particular the Agreement on the application of sanitary and phytosanitary measures (the 'SPS Agreement`);

DESIRING to facilitate trade in live animals and animal products between the Community and Canada while safeguarding animal and public health in relation to the wholesomeness of food products;

RESOLVING to take the fullest account of the risk of spread of animal infection and disease and the measures put in place to control and eradicate such infections and diseases, and in particular to avoid disruptions to trade,

HAVE AGREED AS FOLLOWS:

Article 1 Objective

The objective of this Agreement is to facilitate trade in live animals and animal products between the Community and Canada by establishing a mechanism for the recognition of equivalence of sanitary measures maintained by the two Parties consistent with the protection of public and animal health, and to improve communication and cooperation on sanitary measures.

Article 2 Definitions

For the purposes of this Agreement:

(a) live animals and animal products means the live animals and animal products, including fish and fishery products, listed in Annex I;

(b) sanitary measures means sanitary measures as defined in paragraph 1 of Annex A to the SPS Agreement;

(c) appropriate level of sanitary protection means the appropriate level of sanitary protection as defined in paragraph 5 of Annex A of the SPS Agreement;

(d) region means both 'zone` and 'region` as defined in the Animal Health Code of the Office International des Epizooties (OIE), and for aquaculture as defined in the International Aquatic Animal Health Code of the OIE;

(e) responsible authorities means:

(i) for Canada, the authorities described in Part A of Annex II; and

(ii) for the Community, the authorities described in Part B of Annex II.

Article 3 Scope

1. This Agreement applies in respect of trade between the Community and Canada in live animals and animal products.

2. Subject to paragraph 3, the provisions of this Agreement shall apply initially to sanitary measures of the Parties that apply to trade in live animals and animal products.

3. Unless otherwise specified under the provisions set out in the Annexes to this Agreement, and without prejudice to Article 11, the scope of this Agreement shall exclude sanitary measures related to food additives (all food additives and colours), sanitary stamps, processing aids, flavours, irradiation (ionisation), contaminants (including microbiological standards), transport, chemicals originating from the migration of substances from packaging materials, labelling of foodstuffs, nutritional labelling, animal feedingstuffs, medicated feeds and premixes.

4. The parties may agree to apply the principles of this Agreement to address veterinary issues other than sanitary measures applicable to trade in live animals and animal products.

5. The Parties may agree to modify this Agreement in the future to extend the scope to other sanitary or phytosanitary measures affecting trade between the Parties.

Article 4 Relation to the WTO Agreement

Nothing in this Agreement shall modify the rights or obligations of the Parties under the WTO Agreement and in particular the SPS Agreement.

Article 5 Recognition of regional conditions

1. The Parties recognise the concept of regionalisation, which they agree to apply in respect of the diseases listed in Annex III.

2. Where one of the Parties considers that it has a special status with respect to a specific disease, it may request recognition of that status. The importing Party may also request additional guarantees in respect of imports of live animals and animal products appropriate to the agreed status. The guarantees for specific diseases shall be specified in Annex V.

3. Without prejudice to paragraph 2, the importing Party shall recognise regionalisation decisions taken in accordance with criteria as defined in Annex IV as the basis for trade from a party whose territory is affected by one or more of the diseases listed in Annex III.

Article 6 Recognition of equivalence

1. The importing Party shall recognise a sanitary measure of the exporting Party as equivalent if the exporting Party objectively demonstrates that its measure achieves the importing Party's appropriate level of protection.

2. Once determined, equivalence shall be applied in relation to individual or groups of sanitary measures for live animals or animal product sectors, or parts of sectors, in relation to legislation, inspection and control systems, parts of systems, or in relation to specific legislation, inspections and/or hygiene requirements.

Article 7 Criteria for recognition of equivalence

1. In determining whether a sanitary measure maintained by an exporting Party achieves the importing Party's appropriate level of sanitary protection, the Parties shall follow the process set out below:

(i) identification of the sanitary measures for which recognition of equivalence is sought;

(ii) explanation by the importing Party of the objective of its sanitary measures, including an assessment, as appropriate to the circumstances, of any risks that the sanitary measures are intended to address, and identification by the importing Party of its appropriate level of sanitary protection;

(iii) provision of information by the exporting Party supporting its view that its sanitary measures achieve the importing Party's appropriate level of sanitary protection;

(iv) assessment by the importing Party of whether the exporting Party's sanitary measures achieve the importing Party's appropriate level of sanitary protection; this step may include an evaluation of:

(a) the risks identified by the importing Party and evidence provided by the exporting Party that its sanitary measures effectively address those risks;

(b) the legislation authority, standards, practices and procedures including those of laboratories, as well as the programmes in place to ensure that the domestic requirements of the exporting Party and the importing Party's requirements are met;

(c) the documented structure of the relevant responsible authorities, their command chain, their authority, their operational procedures and the resources available to them; and

(d) the performance of the relevant responsible authorities in relation to the control programme and assurances.

The importing Party may carry out audit and verification procedures, in accordance with Article 10, to assist this assessment.

2. Where equivalence has not been recognised, the conditions for trade shall be those required by the importing Party, as set out in Annex V, to meet its appropriate level of protection. The exporting Party may agree to meet the importing Party's conditions, without prejudice to the result of the process set out in paragraph 1.

3. In carrying out the process described in paragraph 1, and setting the conditions referred to in paragraph 2, the Parties shall take account of experience and information already acquired.

Article 8 Status of the recognition of equivalence of the Parties' sanitary measures

1. Annex V lists those sectors, or parts of sectors, for which at the date of entry into force of this Agreement the Parties' respective sanitary measures are recognised as equivalent for trade purposes.

2. Annex V also lists those sectors, or parts of sectors, for which, at the date of entry into force of this Agreement, the Parties apply different sanitary measures and have not concluded the process described in paragraph 1 of Article 7. The Parties shall carry out the actions set out in Annex V based on the process described in paragraph 1 of Article 7, with the objective of recognising equivalence by the dates indicated in Annex V.

3. With respect to sanitary measures recognised as equivalent for trade purposes at the date of entry into force of this Agreement, the Parties, within their competences, shall initiate the necessary legislative and administrative actions within three months to implement these recognitions.

Article 9 Health certificate

When required, each consignment of live animals or animal products presented for import, and for which equivalence has been recognised, will be accompanied by an official health certificate, the model attestation of which is prescribed in Annex VII. The Parties may jointly determine principles or guidelines for certification. Any such principles or guidelines shall be set out in Annex VII.

Article 10 Audit and verification

1. To maintain confidence in the effective implementation of the provisions of this Agreement, each Party has the right to carry out audit and verification procedures of all or part of the exporting Party's authorities' total control programme as specified in Annex VI.

2. Each Party has the right to carry out frontier checks on consignments on importation, in accordance with Article 11, the results of which may contribute to the audit and verification process.

3. The Community shall carry out the audit and verification procedures provided for in paragraph 1 and the frontier checks provided for in paragraph 2.

4. For Canada, its responsible authorities carry out the audit and verification procedures and frontier checks provided for in paragraphs 1 and 2.

5. Upon the mutual consent of the Parties, either Party may:

(a) share the results and conclusions of its audit procedures and frontier checks with countries that are not Parties to this Agreement, or

(b) use the results and conclusions of the audit procedures and frontier checks of countries that are not Parties to this Agreement.

Article 11 Frontier (import) checks and inspection fees

1. The frequency and nature of frontier checks shall be based on the risk to public and animal health associated with the importation of a live animal or animal product.

2. The frequency rate of frontier checks on imported live animals and animal products shall be as set out in Annex VIII.

3. In the event that frontier checks reveal non-conformity with the relevant import requirements, the action taken by the importing Party shall be based on an assessment of the risk involved.

4. Wherever possible, the importer of a non-conforming consignment, or his representative, shall be notified of the reason for non-conformity, and shall be given access to the consignment and the opportunity to contribute relevant information to assist the importing Party in taking a final decision.

5. A Party may collect fees for the costs incurred in conducting frontier checks. Provisions concerning these fees may be added to Annex VII.

Article 12 Notification and consultation

1. The Parties shall notify each other, in writing, of:

(a) significant changes in health status, such as the presence and evolution of diseases in Annex III, within 24 hours of confirmation of the change;

(b) findings of epidemiological importance with respect to diseases which are not in Annex III or which are new diseases, without delay; and

(c) any additional measures beyond the basic requirements of their respective sanitary measures taken to control or eradicate animal disease or protect public health, and any changes in preventative policies, including vaccination policies.

2. In cases of serious and immediate concern with respect to public or animal health, oral notification shall be made immediately, and written confirmation should follow within 24 hours.

3. Written and oral notifications shall be made to the contact points set out in Annex X.

4. Where a Party has serious concerns regarding a risk to public or animal health, consultations regarding the situation shall, on request, take place as soon as possible, and in any case within 14 days of the request. Each Party shall endeavour in such situations to provide all the information necessary to avoid a disruption in trade, and to reach a mutually acceptable solution.

Article 13 Safeguard clause

A Party may, on serious public or animal health grounds, take provisional measures necessary for the protection of public or animal health. These measures shall be notified to the other Party within 24 hours of the decision to implement them and, on request, consultations regarding the situation shall be held within 14 days of the notification. The Parties shall take due account of any information provided through such consultations.

Article 14 Information exchange

1. The parties shall exchange information relevant to the implementation of this Agreement on a uniform and systematic basis, to provide assurance, engender mutual confidence and demonstrate the efficacy of the programmes controlled. Where appropriate, this may include exchanges of officials.

2. The information exchange on changes in their respective sanitary measures, and other relevant information, shall include:

(a) the opportunity to consider proposals for the introduction of new measures or changes in existing measures, which may affect this Agreement, in advance of their finalisation. Where either Party considers it necessary, proposals may be dealt with in accordance with Article 16(4);

(b) briefing on current developments affecting trade in live animals and animal products;

(c) information on the results of the audit and verification procedures provided for in Article 10.

3. The contact points for this exchange of information are set out in Annex X.

4. The Parties shall provide for the submission of scientific papers or data to the relevant scientific fora to substantiate any views or claims made in respect of a matter arising under this Agreement. Such information shall be evaluated by the relevant scientific fora in a timely manner, and the results of that examination shall be made available to both Parties.

Article 15 Outstanding issues

The principles of this Agreement shall be applied to address outstanding issues affecting trade between the Parties in live animals and animal products as listed in Annex IX. Modifications shall be made to this Annex and, as appropriate, the other Annexes, to take account of progress made and new issues identified.

Article 16 Joint Management Committee

1. A Joint Management Committee (hereinafter referred to as 'the Committee`), consisting of representatives of the Parties is hereby established. The Committee shall consider any matters relating to the Agreement, and shall examine all matters which may arise in relation to its implementation. The Committee shall meet within one year of the entry into force of this Agreement, and at least annually thereafter. The Committee may also address issues out of session by correspondence.

2. The Committee shall, at least once a year, review the Annexes to this Agreement, notably in the light of progress made under the consultations provided for under this Agreement. Following its review, the Committee shall issue a report of its proceedings including any recommendations of the Committee.

3. In the light of the provisions set out in paragraph 2, the Parties may agree to modify the Annexes consistent with the Agreement. Modifications shall be agreed by an exchange of notes.

4. The Parties agree to establish technical working groups consisting of expert-level representatives of the Parties, which shall identify and address technical and scientific issues arising from this Agreement.

When additional expertise is required, ad hoc groups, notably scientific groups, may be constituted by the Parties. Membership of such ad hoc groups need not be restricted to representatives of the Parties.

Article 17 Territorial application

This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied and under the conditions laid down in that Treaty, and on the other hand, to the territory of Canada.

Article 18 Final provisions

1. This Agreement and its Annexes shall enter into force upon an exchange of notes indicating that the Parties have completed all legal requirements necessary for that purpose.

2. Each Party shall implement the commitments and obligations arising from this Agreement and its Annexes in accordance with its internal procedures.

3. Either Party may terminate this Agreement by giving at least six months' notice in writing. The Agreement shall terminate on the expiry of the period of notice.

In witness whereof, the undersigned being duly authorised, have signed this Agreement.

Done in two copies, this seventeenth day of December 1998, in each of the English and French languages, each version being equally authentic.

For the European Community

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For the Government of Canada

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ANNEX I

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ANNEX II

RESPONSIBLE AUTHORITIES

A. Responsible authorities of Canada

The following departments are responsible for the application of sanitary measures in respect of domestically produced, exported and imported animals and animal products and for issuing health certificates attesting to agreed standards unless otherwise noted: the Canadian Food Inspection Agency (CFIA), or the Department of Health, as appropriate.

B. Responsible authorities of the Community

Control is shared between the national services in the individual Member States and the European Communities. In this respect the following applies:

- In terms of exports to Canada, the Member States are responsible for control of the production circumstances and requirements, including statutory inspections and issuing health certification attesting to the agreed standards and requirements.

- The European Commission is responsible for overall coordination, inspection/audits of inspection systems and the necessary legislative action to ensure uniform application of standards and requirements within the Single European Market.

ANNEX III

DISEASES FOR WHICH REGIONALISATION DECISIONS CAN BE TAKEN

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Aquaculture diseases

The list of aquaculture diseases is to be discussed further by the Parties on the basis of the International Aquatic Animal Health code of the OIE.

ANNEX IV

REGIONALISATION AND ZONING

Further to Article 5(3), the Parties agree that the following forms the basis for regionalisation decisions for the diseases listed in Annex III. Each Party agrees to recognise regionalisation decisions taken in accordance with this Annex.

Animal diseases

Regionalisation - Adjacent countries or parts of countries which have the same animal health status and similar disease controls can be treated as a region. The region must be clearly delineated by natural, artificial or legal boundaries which must be effective. The region must have a common control policy for the specific disease. There must be a uniform effective system of epidemiological surveillance throughout the region and an official sanitary agreement between the countries involved.

In assessing risk from a given proposed importation of animals or animal products, three sets of factors may be considered:

1. source risk factors;

2. commodity risk factors;

3. destination risk factors.

Source risk factors

The primary determinant of the risk of importing diseases is the status of the country of origin in respect of the disease in question. However, declarations of disease freedom must be backed up by effective surveillance programmes.

The overriding consideration in this context, therefore, is the quality of the veterinary infrastructure. No other factors can be assessed without full confidence in the veterinary administration. In particular, their ability to detect and control an outbreak of disease and to provide meaningful certification is crucial.

The ability to detect the presence of disease depends on the surveillance carried out. This surveillance can be active, passive, or both.

Active surveillance implies definitive action intended to identify the presence of disease, such as systematic clinical inspections, ante and post mortem examination, serology on farm or in abattoir, referral of pathological material for laboratory diagnosis, sentinel animals.

Passive surveillance means that the disease must be compulsorily notifiable and that there must be a sufficiently high level of supervision of the animals in order to ensure that the disease will be observed quickly and reported as a suspect. There must also be a mechanism for investigation and confirmation, and farmers and veterinarians must have a high level of awareness of the disease and its symptoms.

Epidemio-surveillance may be augmented by voluntary and compulsory herd/flock health programmes, particularly those which ensure a regular veterinary presence on the farm.

Other factors to be considered include:

- disease history,

- vaccination history,

- controls on movements into the zone, out of the zone and within the zone,

- animal identification and recording,

- presence of disease in adjacent areas,

- physical barriers between zones of differing status,

- meteorological conditions,

- use of buffer zones (with or without vaccination),

- presence of vectors and/or reservoirs,

- active control and eradication programmes (where appropriate),

- ante and post mortem inspection system.

On the basis of these factors, a zone may be defined.

The authority with the responsibility for implementing the zoning policy is in the best position to define and maintain the zone. When there is a high level of confidence in that authority, the decisions it makes can be the basis for trade.

The zones so defined may be assigned a risk category.

Possible categories are:

- low/negligible risk,

- medium risk,

- high risk,

- unknown risk.

Calculation of estimates of risk for e.g. live animals may assist in this categorisation. Import conditions may then be defined for each category, disease and commodity, individually or in groups.

Low/negligible risk implies that importation may take place based on a simple guarantee of origin.

Medium risk implies that some combination of certification and/or guarantees may be required before or after importation.

High risk implies that importation will only take place under conditions which significantly reduce the risk, e.g. by additional guarantees, testing or treatment.

Unknown risk implies that imports will only take place if the commodity itself is of very low risk, e.g. hides, wool, or under the conditions for 'high risk` if the commodity factors warrant.

Commodity risk factors

These include:

- is the disease transmissible by the commodity?

- could the agent be present in the commodity if derived from a healthy and/or clinically affected animal?

- can the predisposing factor be reduced, e.g. by vaccination?

- what is the likelihood that the commodity has been exposed to infection?

- has the commodity been obtained in such a way as to reduce the risk, e.g. deboning?

- has the commodity been subjected to a treatment which inactivates the agent?

Appropriate tests and quarantine will reduce the risk.

Destination risk factor

- presence of susceptible animals;

- presence of vectors;

- possible vector-free period;

- preventive measures such as waste food feeding and animal waste rendering rules;

- intended use of product e.g. petfood, human consumption only.

These factors are inherent in or are under the control of the importing country, and some may therefore be modified to facilitate trade. These may, for example, include restricted entry conditions e.g. animals to be confined to a certain vector-free region until the incubation period has passed, or canalisation systems. However, destination risk factors will also be taken into account by the infected country with respect to the risk presented by movements from the infected part to the free part of its territory.

Aquaculture diseases

Pending the development of any specific provisions to be included in this Annex, the basis for regionalisation decisions for aquaculture diseases will be the International Aquatic Health Code of the OIE.

ANNEX V

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8. Compliance with EC water testing requirements.

9. Compliance with EC requirements on medical health certificates.

10. No export of mechanically recovered meat.

11. Meat must not be treated with tenderisers, or come from animals treated with hormonal growth promoters.

12. For trade from Canada to Sweden and Finland, Canada will certify in accordance with Council Decision 95/409/EC (fresh: veal, beef and pigmeat), Council Decision 95/410/EC (live poultry for slaughter), Council Decision 95/411/EC (fresh poultrymeat), Commission Decision 95/160/EC (breeding poultry and day-old chicks), and Commission Decision 95/161/EC (laying hens).

No attestation is required for consignments of fresh meat as defined in Directive 72/462/EEC intended for an establishment for the purposes of pasteurisation, sterilisation or for treatment having an equivalent effect.

13. Wood shall not be used for pens for sick and suspect animals.

Pens for sick and suspect animals shall be sited and constructed to preclude contact with animals intended for slaughter for export to the EC and effluent from such pens shall not flow into adjoining pens or passageways.

14. Separate office for inspection officials in cutting plants.

15. Hides must be removed from veal.

16. Trichina testing of horsemeat and pigmeat in accordance with Directive 77/96/EEC.

17. Shrouds not to be used on carcases.

18. Compliance with EC rules on veterinary post-mortem and post-mortem inspection.

19. Compliance with EC rules on counter-flow chillers (Directive 71/118/EEC).

20. Compliance with EC rules on decontamination.

II. EC EXPORTS TO CANADA

1. Ensure separation of waste water and other effluents necessary to prevent backflow contamination.

2. Room temperatures not to exceed:

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Product temperatures for refrigerated meat products not to exceed 4 °C.

3. Continuous assessment of health status of employees. Details on systems in place in Member States to be provided.

4. Compliance with Canada rules on post-mortem inspection for poultry.

Footnote B

Fisheries products for human consumption

I. CANADIAN EXPORTS TO THE EC:

1. For identification purposes, products should bear the Canadian registration number of the production facility, in accordance with Chapter VII of the Appendix to Directive 91/493/EEC.

2. Processing plants must have automatic temperature recorders in frozen fish storage areas and non-hand operated wash-basins in processing areas.

3. Cooked shellfish must meet the microbiological standards established in Decision 93/51/EEC.

4. Aquaculture products must meet the maximum residue levels as prescribed by Council Regulation (EC) No 3277/90.

5. All shipments of live lobsters and eels must meet the requirements for export under the 'Canadian Live Fish Certification Protocol`.

II. EC EXPORTS TO CANADA

1. Products must be labelled with the approved EC number, as per Directive 91/493/EEC.

2. Products must meet the microbiological guidelines as defined by the Canadian bacteriological guidelines for fish and fish products.

3. Products must meet the Canadian guidelines for chemical contaminants and toxins in fish and fish products.

4. Smoked fish packed in hermetically sealed containers must be frozen or contain a salt level not less than 9 % (water phase method).

5. Aquaculture products must meet the Canadian guidelines for therapeutant use.

Footnote C

Live bivalve molluscs for human consumption

I. CANADIAN EXPORTS TO THE EC:

1. The original harvest site must be within Canada.

2. Product must be destined for direct human consumption and not for wet storage, relaying or depuration in EC.

3. Labelling on each bag or container must be marked with the species of shellfish (common and scientific names), the official registration number identifying the processing plant (dispatch center) and the packing date.

4. Products must meet the microbiological and toxicological standards established in Chapter V of the Appendix to Directive 91/492/EEC.

II. EC EXPORTS TO CANADA:

1. The original harvest site must be within the EC.

2. Product must be destined for direct human consumption and not for wet storage, relaying or depuration in Canada.

3. Labelling on each bag or container must include the common name of the shellfish, date and area of harvest, name, address and registration number of the dispatch center.

4. Products must meet the microbiological guidelines as defined by the Canadian Bacteriological Guidelines for Fish and Fish Products.

5. Products must meet the Canadian Guidelines for Chemical Contaminants and Toxins in Fish and Fish Products.

Footnote D

Live bovine animals and bovine semen - IBR

Canada will certify in accordance with Article 3 of Commission Decision 93/42/EEC or Article 2 of Commission Decision 95/109/EC as appropriate for exports to Member States or regions of Members States which have been granted special conditions for intra-Community trade.

Footnote E

Live porcine animals and porcine semen - Aujeszky's disease

Canada will certify in accordance with Article 5 of Commission Decision 93/24/EEC or Article 4 of Commission Decision 93/244/EEC as appropriate for exports to Member States or regions of Member States which have been granted special conditions for intra-Community trade.

ANNEX VI

GUIDELINES ON PROCEDURES FOR CONDUCTING AN AUDIT

1. General principles

1.1. Audits should be made in cooperation between the auditing party (the 'auditor`) and the audited party, (the 'auditee`) in accordance with the provisions set out in this Annex.

1.2. Audits should be designed to check the effectiveness of the controlling authority rather than to reject individual animals, groups of animals, consignments of food or establishments. The process can include study of the relevant regulations, method of implementation, assessment of the end result, including assessments conducted, as considered necessary, at establishments or facilities, level of compliance and subsequent corrective actions. Where an audit reveals a serious risk to animal or human health, the auditee shall take immediate corrective action.

1.3. The frequency of audits should be based on performance. A low level of performance should result in an increased frequency of audit; unsatisfactory performance must be corrected by the auditee to the auditor's satisfaction.

1.4. Audits, and the decisions based on them, shall be made in a transparent and consistent manner.

2. Principles relating to the auditor

Those responsible for conducting the audit should prepare a plan, preferably in accordance with recognised international standards, that covers the following points:

2.1. the subject, depth and scope of the audit;

2.2. the date and place of the audit, along with a timetable up to and including the issue of the final report;

2.3. the language or languages in which the audit will be conducted and the report written;

2.4. the identity of the auditors including, if a team approach is used, the leader. Specialised professional skills may be required to carry out audits of specialised systems and programmes;

2.5. a schedule of meetings with officials and visits to establishments or facilities, as appropriate. The identity of establishments or facilities to be visited should be stated in advance, although additional or alternate facilities may be visited during the audit if it is considered necessary;

2.6. subject to provisions on freedom of information, respect of commercial confidentiality shall be observed by the auditor. Conflicts of interest must be avoided;

2.7. respect of the rules governing occupational health and safety.

This plan should be reviewed in advance with representatives of the auditee.

3. Principles relating to the auditee

The following principles apply to actions taken by the auditee, in order to facilitate audit.

3.1. The auditee must cooperate fully with the auditor and should nominate personnel responsible for this task. Cooperation may include, for example:

- access to all relevant regulations and standards,

- access to compliance programmes and appropriate records and documents,

- access to audit and inspection reports,

- documentation concerning corrective actions and sanctions,

- facilitating entry to establishments or facilities.

3.2. The auditee must operate a documented programme to demonstrate to the auditor that standards are being met on a consistent and uniform basis.

4. Procedures

4.1. Opening meeting

An opening meeting should be held between representatives of both parties. At this meeting the auditor will be responsible for reviewing the audit plan and confirming that adequate resources, documentation, and any other necessary facilities are available for conducting the audit.

4.2. Document review

The document review may consist of a review of the documents and records referred to in paragraph 3.1, the structures and powers of the auditee, and any relevant changes to food inspection and certification systems since the adoption of this Agreement or since the previous audit, with emphasis on the implementation of elements of the system of inspection and certification for animals or products of interest. This may include an examination of relevant inspection and certification records and documents.

4.3. On-site verification

4.3.1. The decision to include this step should be based upon an assessment of risk, taking into account factors such as the animals or products concerned, the history of conformity with requirements by the industry sector or exporting country, the volume of product produced and imported or exported, changes in infrastructure and the nature of the inspection and certification systems.

4.3.2. On-site verification may involve visits, which may be unannounced, to production and manufacturing facilities, food handling or storage areas and control laboratories to check on compliance with the information contained in the documentary material referred to in 4.2.

4.4. Follow-up audit

Where a follow-up audit is being conducted in order to verify the correction of deficiencies, it may be sufficient to examine only those points which have been found to require correction.

5. Working documents

Working documents may include checklists of elements to evaluate, such as the following:

- legislation,

- structure and operations of inspection and certification services,

- establishment details and working procedures (including any HACCP documentation),

- health statistics, sampling plans and results,

- compliance action and procedures,

- reporting and complaint procedures, and

- training programmes.

6. Closing meeting

A closing meeting shall be held between representatives of both Parties. At this meeting the auditor will present the findings of the audit. The information should be presented in a clear, concise manner so that the conclusions of the audit are clearly understood.

The Parties may discuss specific actions to be taken as the result of the findings.

7. Audit report

The auditor shall provide the auditee with a draft report of the audit generally within 60 days of the conclusion of the audit. To the extent possible, the report shall be presented in a standardised format to be agreed upon by the Parties in order to make the approach to audit more uniform, transparent and efficient. The report will assess the adequacy of the auditee's enforcement and control programme and identify any deficiencies noted during the conduct of the audit. Thereafter, the auditee may within 60 days comment on the draft report and shall describe any specific corrective actions that will be taken, preferably with target dates for completion. Any comments made by the auditee shall be included in the final report.

ANNEX VII

CERTIFICATION

Official health certificates will cover consignments of live animals and/or animal products being traded between the Parties.

Health attestations:

(a) Equivalence agreed

Model health attestation to be used ('yes 1` for animal and/or public health).

'The live animals or animal products herein described comply with the relevant European Community/Canadian standards and requirements which have been recognised as equivalent to the Canadian/European Community standards and requirements as prescribed in the Canadian/EC Veterinary Agreement. Specifically in accordance with (insert: exporting country's legislation)`.

(b) Until certificates on the basis of equivalence have been adopted, existing certification shall continue to be used as set out in Annex V.

Language:

Exports from Canada: the official health certificate will be issued either in English or French or both as well as in one of the languages of the Member State in which the border inspection post is situated and where the consignment is presented.

Exports from the EC: the official health certificate will be issued in the language of the Member State of origin as well as either in English or French or both.

ANNEX VIII

FRONTIER CHECKS

Frequencies of frontier checks on consignments of live animals and animal products

The Parties may modify any frequency rate, within their responsibilities, as appropriate, taking into account the nature of any checks applied by the exporting Party prior to export, the importing Party's past experience with products imported from the exporting Party, any progress made toward the recognition of equivalence, or as a result of other actions or consultations provided for in this Agreement.

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For the purposes of this Agreement, 'consignment` means a quantity of products of the same type, covered by the same health certificate or document, conveyed by the same means of transport, consigned by a single consignee and originating from the same exporting Party or part of such Party.

ANNEX IX

OUTSTANDING ISSUES

1. The Parties agree that the following areas are to be explored as part of a work programme:

- contaminants (including microbiological standards),

- food additives,

- animal feeding stuffs,

- medicated feeds and premixes,

- labelling of foodstuffs,

- nutritional labelling,

- flavours,

- processing aids,

- chemicals originating from the migration of substances from packaging materials,

- irradiation,

- sanitary stamps,

- zootechnical standards.

2. Canada has submitted a document outlining a proposed model for a risk based import inspection model. There is agreement between the Parties to explore the possibility of implementing this approach.

3. The Parties agree to discuss issues associated with the transit of live animals through the territory of the Parties.

ANNEX X

CONTACT POINTS FOR THE ADMINISTRATION OF THIS AGREEMENT

A Party may unilaterally amend its section of this Annex. Such amendments shall be notified to the other Party without delay, and shall come into force on the date specified in the notification, but shall not come into force prior to the date of the notification.

Pursuant to Article 14(3), the following are the contact points for each of the Parties.

For Canada

The initial contact point is:

Agriculture Counsellor

Agriculture Section

Canadian Mission to the European Union

Avenue de Tervuren/Tervurenlaan 2

B-1040 Brussels;

Telephone: (32) 2 741-0610 (Agriculture Counsellor)

(32) 2 741-0698 (Agricultural Affairs Assistant)

(32) 2 741-0611 (Switchboard)

Fax: (32) 2 741-0629

Other important contacts are:

For matters related to live animals, agri-food, fish, and seafood products:

Executive Director

Animal Products Directorate

Canadian Food Inspection Agency

59 Camelot Drive

Nepean, Ontario

K1A 0Y9

Telephone: (613) 225-2342

Fax: (613) 228-6631

For matters specifically related to fish health and diseases:

Director

Aquaculture and Oceans Science Branch

Department of Fisheries and Oceans

200 Kent Street

Ottawa, Ontario

K1A 0E6

Telephone: (613) 990-0275

Fax: (613) 954-0807

For matters related to human health:

Director General

Food Directorate

Health Protection Branch

Health Canada

Health Protection Building, Tunney's Pasture

Ottawa, Ontario

K1A 0L2

For the Community

The initial contact point is:

The Director

DG VI.B.II Quality and Health

Commission of the European Communities

Rue de la Loi/Wetstraat 86 (Room 8/53)

Brussels;

Telephone: (32) 2 295 6838

Fax: (32) 2 296 4286